Pramipexole Dihydrochloride
- Product NDC
- 13668-184
- 11-digit product format
- 136680184
- Labeler code
- 13668
- Product ID
- 13668-184_f3214c59-f86f-47d6-9ddb-0af985d11a6c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pramipexole Dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA090865
- Marketing category
- ANDA
- Marketing start
- 2010-10-08
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- .75 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pramipexole Dihydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | .75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3D867NP06J |
| Rxcui | 858625, 859033, 859040, 859044, 859048, 859052 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13668-184-05 | Pramipexole Dihydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 22 |
| 13668-184-30 | Pramipexole Dihydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 22 |
| 13668-184-31 | Pramipexole Dihydrochloride | 2500 in 1 BOTTLE | TABLET | 2500 | | 22 |
| 13668-184-90 | Pramipexole Dihydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 22 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13668-184 | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED] | 20 | Current NDC, Legacy NDC, 4 package rows | 20240816_60167d7c-469f-455a-a113-561841af5e59.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 13668-184-05 | 13668018405 | 500 TABLET in 1 BOTTLE (13668-184-05) | 500 tablet | 2010-10-08 | 0000-00-00 | No | No | Current |
| 13668-184-30 | 13668018430 | 30 TABLET in 1 BOTTLE (13668-184-30) | 30 tablet | 2010-10-08 | 0000-00-00 | No | No | Current |
| 13668-184-31 | 13668018431 | 2500 TABLET in 1 BOTTLE (13668-184-31) | 2500 tablet | 2010-10-08 | 0000-00-00 | No | No | Current |
| 13668-184-74 | 13668018474 | 100 TABLET in 1 CARTON (13668-184-74) | 100 tablet | 2010-10-08 | 0000-00-00 | No | No | Current |
| 13668-184-90 | 13668018490 | 90 TABLET in 1 BOTTLE (13668-184-90) | 90 tablet | 2010-10-08 | 0000-00-00 | No | No | Current |